Equipment QualificationPACT WebinarJanuary 29, 2009

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Equipment Qualification

What is It?

When is it Done?

What is Involved?

Summary

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Qualification

Performed to “Establish confidence that process equipment & ancillary systems are capable of consistently operating within established limits & tolerances”

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Validation

The purpose of validation is“to ensure that user needs and intended uses can be fulfilled on a consistent basis”It is “confirmation by examination and provision of objective evidence that specified requirements for a particular device or activity have been met”

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ValidationHelpful Information

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Components of Qualification

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Requalification (RQ)

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Design Qualification

Pre-sets the specifications required for equipment

Performed prior to purchase

Describes the features required for the equipment

Outlines the decision process used to select the equipment

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Design Qualification Considerations

Capabilities (e.g. speed, capacity & temperature for a centrifuge)Requirements (e.g. voltage, size limitations, operational specifications, requirement to work with existing instruments)Features (e.g. ease of cleaning PC interface, self calibrating, service contracts)May result in sole source availability –usually requires justification

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Design Qualification CAGT

Indicate the requirements the equipment must meet

Equipment description e.g. Centrifuge

SpecificationsElectrical

Tolerances/Performance

Maintenance/Cleaning

Other

Reasons for selection of this Model

Individual responsible for this selection

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Installation Qualification

Documents

When and where received

Condition upon receipt

Complete order received?

Transportation to site of use

Unpacking

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Installation Qualification

Documents

Installation (by whom, where, when)

Start up (self check etc.)

Calibration and cleaning

SOP for maintenance and use?

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Installation QualificationCAGT

Date of DeliveryOrder complete?Manual received? (hardcopy/electronic)Location for Installation

Meets manufacturer’s specifications (Temp/Voltage etc.)

Name of InstallerPower up worked (Yes/No/N/A)Self check passed (Yes/No/N/A)Service/Calibration plan established (Details)OtherIndividual completing this section

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Operational QualificationDoes the equipment function as described by manufacturer?

Confused with Validation

OQ for a centrifugeDoes the centrifuge turn on and off

Spin at programmed speed & temperature

Brake as set

Retain programming

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Operational QualificationCAGT

Describe specifications to be testedAccuracy of settings, maintenance of temperature etc.

Has the equipment been calibratedBy whom (Attach calibration documents)

Has an SOP been writtenIf no, then must be done before equipment put into use

Individual completing this section

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Performance Qualification

Does the equipment function correctly and consistently for the intended applicationAnalogous to Validation but here the emphasis is on whether a piece of equipment rather than a process is working appropriately

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Performance QualificationCAGT

For critical pieces of equipment it may be necessary to perform a Performance Qualification to ensure that it will function properly when used in a specific manufacturing procedure.

Does this equipment require Performance Qualification (Check with Quality Assurance)

If No, turn in completed forms and attachments to Quality Assurance for review

If Yes, proceed to Section 6, Performance Qualification page of the worksheet

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Performance QualificationCAGT

Provide evidence that the equipment is performing as expected when used in a manufacturing procedure.

The PQ will be performed using

Mock product(s)Clinical materials intended for therapeutic use. This requires pre-approval from QA, the patient’s physician and a Laboratory Medical Director.

Describe safeguards to be taken to protect patient in case of a manufacturing failure.

The proposed Performance Qualification is pre-approved for use on clinical materials

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Performance QualificationCAGT

Centrifuge performance qualificationDoes the use of this centrifuge in this procedure (e.g. density gradient separation) produce the expected results based on:

Previous results with other centrifugesPublished results on the same procedureResults using same procedure at other sitesResults from the manufacturer

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Performance QualificationPQ plan submitted to QA for pre-approvalDescribes

Procedure to be performedParameters for determining successAllowable tolerancesData to be collectedAnalysis of data to be performed

The results are submitted to QA to determine if acceptable for final qualification of equipment

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RequalificationDetermine necessity in consultation with QA

After any incident that may affect equipment performance

After equipment repair

After equipment upgrade or service

After equipment is moved

After facility incident – power surge, closure etc.

If equipment is to be used in new way

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Qualification Summary• Evidence that equipment operates

consistently within established limits• Performed in stages

• Design• Installation• Operation• Performance• Requalification

• Information evaluated independently by Quality Assurance